Drug-makers to add Hyponatraemia as adverse effect in package insert of Olanzapine: CDSCO Panel
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has recommended that CDSCO may request State Drugs Controllers to direct the manufacturers of antipsychotic drug Olanzapine to include adverse drug reaction named Hyponatraemia in the package insert of the drug.
Hyponatremia is a low sodium concentration in the blood. It is generally defined as a sodium concentration of less than 135 mmol/L (135 mEq/L), with severe hyponatremia being below 120 mEq/L. Symptoms can be absent, mild or severe. Mild symptoms include a decreased ability to think, headaches, nausea, and poor balance. Severe symptoms include confusion, seizures, and coma.
This came in line with the recommendation of the signal review panel of National Coordinating Centre(NCC) -Pharmacovigilance Programme of India (PvPI), which was placed before the committee.
Olanzapine is an antipsychotic drug used in the management of schizophrenia, bipolar 1 disorder, and agitation associated with these disorders.
The activity of olanzapine is achieved by the antagonism of multiple neuronal receptors including the dopamine receptor D1, D2, D3 and D4 in the brain, the serotonin receptors 5HT2A, 5HT2C, 5HT3 and 5HT6, the alpha-1 adrenergic receptor, the histamine receptor H1 and multiple muscarinic receptors.
A few brands of olanzapine include Sun Pharma's Oleanz 5mg Tab, Oleanz Rapitab 5mg, Lupin's Jolyon MD 5mg Tablet, Cadila Pharma's Pine-5 Tab, Torrent Pharma's Tolaz MD 5mg Tablet etc.
At a recent SEC meeting for neurology & psychiatry, the recommendation of the signal review panel, PVPI, IPC, was placed before the committee regarding the Olanzapine associated Hyponatraemia.
In view of the above, after detailed deliberation, the committee recommended,
"CDSCO should request the State Drugs Controllers to direct the manufacturers to include ADR of Olanzapine associated Hyponatraemia in the package insert of the drug marketed in the country."
